OBJECTIVES: Managed entry agreements are used for prescription drugs in Sweden since 2015 to facilitate market access when the traditional reimbursement pathway is unfeasible. This has resulted in several drugs having confidential prices. As new treatments enter the market, using drugs with confidential prices as comparators in cost-effectiveness analyses have been proven difficult. The aim of this study is to provide an overview of how this situation is dealt with by the Dental and Pharmaceutical Benefits Agency (TLV) in Sweden.

METHODS: Cases where the relevant comparator to the new drug was a drug with a confidential price were identified through a review of TLV decisions. Data on the clinically relevant comparator, comparator requested by TLV if other than the clinically relevant comparator, and justification for the request were extracted.

RESULTS: In several cases where the clinically relevant comparator to a new drug (drug B) is a drug with a confidential price (drug A), TLV have instead requested a different comparator in the cost effectiveness model (drug C). This comparator is usually identical to the comparator to drug A in its original reimbursement application, or a drug with similar treatment effect. The cost effectiveness of drug B to drug A in thereafter assessed indirectly by comparing the incremental cost effectiveness ratio for drug B vs drug C with that for drug A vs drug C. TLV justify this method with not being able to disclose the confidential price of drug B to the manufacturer of drug A.

CONCLUSIONS: TLVs procedure of handling reimbursement applications when the clinically relevant comparator to a new drug has a confidential price is logical. However, the procedure creates problems for the manufacturers as the health economic model in Sweden will differ from other markets where authorities have other ways of handling this situation.